Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:44 AM
Study NCT ID:
NCT07415720
Status:
RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-01-20', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HOMA-IR and body weight', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5 30. HOMA-IR is a good measurement of insulin resistance since it has a very good correlation with the gold standard test hyperinsulinemic-euglycemic clamp (r\\>0.88, p\\<0.0001).'}], 'secondaryOutcomes': [{'measure': 'Fasting glucose (mmol/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Concentration of glucose in venous blood measured after an overnight fast of at least 8 hours, expressed in millimoles per liter (mmol/L). It reflects basal glycemic control and is used to assess glucose metabolism and risk of type 2 diabetes.'}, {'measure': 'Fasting insulin (µU/mL)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Concentration of insulin in venous blood measured after an overnight fast of at least 8 hours, expressed in micro-units per milliliter (µU/mL). It reflects basal insulin secretion and is used to evaluate insulin sensitivity and resistance.'}, {'measure': 'HbA1c (%)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Percentage of glycated hemoglobin in whole blood, reflecting the average blood glucose concentration over the previous 2-3 months. It is used to assess long-term glycemic control and risk of type 2 diabetes.'}, {'measure': 'HOMA-IR Index', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'The HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) index is a diagnostic tool used to measure insulin resistance and beta-cell function by evaluating the relationship between fasting plasma insulin (FPI) and fasting plasma glucose (FPG).'}, {'measure': 'HOMA-B index', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'An index estimating pancreatic β-cell function derived from fasting glucose and fasting insulin concentrations using the Homeostasis Model Assessment (HOMA) method. It reflects basal insulin secretory capacity.'}, {'measure': 'Gut microbial diversity', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Alpha diversity indices (e.g., Shannon, Simpson) and beta diversity metrics to assess overall community structure changes.'}, {'measure': 'Gut microbiota taxonomic composition', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Relative abundance of gut microbiota bacterial taxa at different phylogenetic levels and their changes over time between intervention groups.'}, {'measure': 'Microbial functional pathways related to metabolic health', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Abundance of microbial metabolic pathways related to short-chain fatty acid production, polyphenol metabolism, and inflammation.'}, {'measure': 'Urinary polyphenol-derived metabolites (mmol/24 h).', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': '24-hour urinary excretion of polyphenol metabolites (e.g., phenolic acids).'}, {'measure': 'Urinary metabolomic profile', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Relative abundance of urinary metabolites identified by metabolomic analysis.'}, {'measure': 'Epigenome-wide DNA methylation analysis', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'DNA methylation analysis will be performed using genomic DNA extracted from peripheral blood buffy coat samples.'}, {'measure': 'Differentially methylated CpG sites (Δβ-value)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Differences in the change of DNA methylation at CpG sites between intervention groups.'}, {'measure': 'Epigenetic age acceleration (years)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Epigenetic age acceleration estimated from DNA methylation clocks. Unit: Years (difference between epigenetic biological age and chronological age).'}, {'measure': 'Body Mass Index (BMI) (kg/m²)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Calculated as body weight divided by height squared to assess overall adiposity.'}, {'measure': 'Waist circumference (cm)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured to evaluate central adiposity and cardiometabolic risk.'}, {'measure': 'Fat mass (kg)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Assessed by dual-energy X-ray absorptiometry (DEXA) to quantify total body fat.'}, {'measure': 'Fat mass (%)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Assessed by dual-energy X-ray absorptiometry (DEXA) to quantify percentage of body fat.'}, {'measure': 'Visceral Adipose Tissue (VAT) (g or cm²)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Assessed by dual-energy X-ray absorptiometry (DEXA) to quantify visceral fat mass as an indicator of cardiometabolic risk.'}, {'measure': 'Total cholesterol (mmol/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured enzymatically to assess lipid metabolism and cardiovascular risk.'}, {'measure': 'Low-density lipoprotein cholesterol (LDL-c) (mmol/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured enzymatically as a marker of atherogenic lipid particles.'}, {'measure': 'High-density lipoprotein cholesterol (HDL-c) (mmol/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured enzymatically as a marker of cardioprotective lipid fraction.'}, {'measure': 'Triglycerides (mmol/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured enzymatically as an indicator of lipid metabolism and metabolic health.'}, {'measure': 'C-reactive protein (CRP) (mg/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured to assess systemic low-grade inflammation.'}, {'measure': 'Tumor necrosis factor-alpha (TNF-α) (pg/mL)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured by ELISA to assess pro-inflammatory cytokine activity.'}, {'measure': 'Interleukin-6 (IL-6) (pg/mL)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured by ELISA to assess inflammatory signaling.'}, {'measure': 'Oxidized LDL (LDLox) (U/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured by ELISA as a marker of oxidative stress and atherogenic risk.'}, {'measure': 'Alanine transaminase (ALT) (U/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured to assess hepatocellular function.'}, {'measure': 'Aspartate aminotransferase (AST) (U/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured to assess liver and metabolic health.'}, {'measure': 'Gamma-glutamyl transpeptidase (GGT) (U/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured to assess liver function and oxidative stress status.'}, {'measure': 'Blood urea (mmol/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured to assess renal function and protein metabolism.'}, {'measure': 'Blood creatinine (µmol/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured to assess renal filtration capacity.'}, {'measure': 'Estimated Glomerular Filtration Rate (eGFR) (mL/min/1.73 m²)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Estimated glomerular filtration rate will be calculated to assess renal function using serum creatinine, age, and sex. eGFR will be estimated using the CKD-EPI equation based on serum creatinine concentration.'}, {'measure': 'Blood albumin (g/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured as an indicator of nutritional and inflammatory status.'}, {'measure': 'Uric acid (µmol/L)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Measured to assess purine metabolism and cardiometabolic risk.'}, {'measure': 'Total intervention adherence (%)', 'timeFrame': 'From enrollment to the end of treatment at 16 weeks.', 'description': 'Calculated as the percentage of the prescribed intervention consumed during the study period, based on returned product counts and/or predefined adherence criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabete Type 2', 'Obesity & Overweight', 'Insulin Resistance Syndrome']}, 'descriptionModule': {'briefSummary': 'The ARTI-UP study evaluates whether daily consumption of a supplement made from artichoke by-products, rich in hydroxycinnamic acids (HCAs), in combination with an energy-restricted Mediterranean diet (erMeDiet), can improve glycaemic control, reduce insulin resistance and contribute to weight loss in subjects with overweight or obesity. In addition, it seeks to understand the biological mechanisms involved using omic techniques and to establish predictive biomarkers that will enable progress towards personalised nutrition strategies.', 'detailedDescription': 'Type 2 diabetes (T2D) and obesity represent major global public health challenges, largely driven by insulin resistance and excess body weight. Lifestyle interventions based on energy-restricted Mediterranean dietary patterns have demonstrated beneficial effects on glycemic control and body weight; however, substantial interindividual variability in response persists. Emerging evidence suggests that specific dietary bioactive compounds, such as hydroxycinnamic acids (HCAs), may play a relevant role in improving insulin sensitivity, yet their contribution within structured dietary interventions remains insufficiently explored.\n\nIn this context, the hypothesis of the present study is that daily supplementation with an artichoke by-product powder rich in bioavailable HCAs, administered within an energy-restricted Mediterranean diet (erMeDiet), will lead to greater improvements in insulin resistance and body weight compared with an erMeDiet alone in overweight and obese adults with insulin resistance. Furthermore, interindividual variability in response to HCAs is hypothesized to be partially explained by differences in metabolic, microbiota-related, and epigenetic profiles.\n\nFollowing recruitment and screening, the study will consist of a 16-week randomized, controlled, double-blind, parallel-group lifestyle intervention. Participants will be randomly assigned (1:1) to one of two intervention arms:\n\nIntervention group: Energy-restricted Mediterranean diet (approximately -500 kcal/day) combined with physical activity counselling and daily supplementation with an artichoke by-product powder providing a minimum of 600 mg/day of bioavailable hydroxycinnamic acids.\n\nControl group: Energy-restricted Mediterranean diet and identical physical activity counselling, supplemented with an isocaloric placebo powder matched for macronutrient composition but devoid of HCAs.\n\nAll participants will receive individualized dietary counselling and guidance to achieve at least 150 minutes per week of moderate-intensity physical activity. Clinical visits will be conducted at baseline and throughout the intervention to monitor adherence, collect biological samples, and assess outcomes.\n\nThe primary outcomes of the study are changes in insulin resistance, assessed by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), and changes in body weight after 16 weeks of intervention. Secondary outcomes include changes in anthropometric parameters, glucose metabolism markers, lipid profile, inflammatory and oxidative stress markers, dietary intake, physical activity, and continuous glucose monitoring metrics.\n\nIn addition, a comprehensive multi-omics approach will be applied to investigate the biological mechanisms underlying the effects of HCAs. This includes targeted and untargeted metabolomics, gut microbiota metagenomics, and genome-wide DNA methylation analyses. Machine learning methods will be used to integrate clinical and omics data in order to identify biomarkers predictive of individual response to the intervention, contributing to the advancement of precision nutrition strategies for T2D prevention.\n\nThis study aims to provide robust clinical and mechanistic evidence supporting the use of sustainable, upcycled plant-based bioactive compounds as complementary dietary tools for improving insulin resistance and preventing type 2 diabetes in high-risk populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 25.0 and 35.0 kg/m²\n* HOMA-IR ≥ 2.5.\n* Adequate physical examination and vital signs or clinically irrelevant to the intervention (those not related to metabolic health).\n* Subjects must be able to understand and be willing to sign the informed consent form, and must comply with all study procedures and requirements.\n* Subjects must have a stable means of communication, either by email and/or telephone.\n\nExclusion Criteria:\n\n* Weight loss of more than 5% in the last 6 months prior to surgery.\n* Consumption of antibiotics in the 3 months prior to the intervention.\n* Subjects who are undergoing treatment for weight loss/body composition modification, use medication for weight loss or blood glucose control, or have had weight loss surgery.\n* Have a medical diagnosis of type 1 or type 2 diabetes.\n* History of inflammatory bowel disease and/or resection of the large or small intestine. Subjects with relevant functional or structural abnormalities of the digestive system.\n* Inability to follow the recommended diet or physical exercise.\n* Unavailability in terms of time or location to attend study visits.\n* Failure to sign the informed consent form.\n* Inability to communicate with the research team.\n* Endocrine-related excess weight (except for treated hypothyroidism, at least 3 months of stable treatment).\n* Being pregnant or planning a pregnancy during the intervention period.\n* Being breastfeeding.\n* Having an allergy to artichokes.\n* Severe psychiatric illnesses that have required hospitalisation in the last 6 months.\n* Renal failure.\n* Having immunodeficiency or being HIV positive.\n* Being treated with immunosuppressive drugs or cytotoxic agents.\n* High alcohol intake: more than 14 units (women) and 20 units (men) per week.\n* Participation in another randomised clinical trial.\n* Volunteers undergoing drug treatment for less than 3 months with a stable dose/stable treatment.\n* Taking nutritional supplements (supplements: plant derivatives, for weight loss, fibre and probiotics) unless the person is willing to stop taking them for 3 months prior to the start of the trial.\n* Taking nutritional supplements (supplements: plant-derived, for weight loss, fibre and probiotics) unless the person is willing to stop taking them for the 16 weeks of the study intervention and a minimum washout period of 14 days prior to baseline measurements is guaranteed.\n* Having donated blood in the 14 days prior to the baseline visit.\n* Subjects with any type of cancer or undergoing treatment for cancer, or who have not been in remission for at least 5 years.\n* Any other condition that may interfere with adherence to the intervention.'}, 'identificationModule': {'nctId': 'NCT07415720', 'acronym': 'ARTI-UP', 'briefTitle': 'Artichoke By-products Rich in Hydroxycinnamic Acids and Mediterranean Diet for Type 2 Diabetes Prevention.', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'Multiomic Evaluation of the Effect of Artichoke By-products Supplementation Rich in Hydroxycinnamic Acids, Integrated Into an Energy-restricted Mediterranean Diet, on the Prevention of Type 2 Diabetes.', 'orgStudyIdInfo': {'id': 'ARTI-UP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group: erMeDiet + artichoke capsules', 'description': 'Participants will follow a energy-restricted Mediterranean diet and consume artichoke by-product capsules daily for 16 weeks.', 'interventionNames': ['Dietary Supplement: Artichoke by-product capsules', 'Behavioral: Energy-restricted Mediterranean diet (erMeDiet)', 'Behavioral: Physical activity']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group: erMeDiet + placebo capsules', 'description': 'Participants will follow an energy-restricted Mediterranean diet and consume placebo capsules daily for 16 weeks.', 'interventionNames': ['Behavioral: Energy-restricted Mediterranean diet (erMeDiet)', 'Dietary Supplement: Placebo capsules', 'Behavioral: Physical activity']}], 'interventions': [{'name': 'Artichoke by-product capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The intervention group will consume artichoke by-product capsules for 16 weeks.', 'armGroupLabels': ['Intervention group: erMeDiet + artichoke capsules']}, {'name': 'Energy-restricted Mediterranean diet (erMeDiet)', 'type': 'BEHAVIORAL', 'description': 'All study participants will follow an energy-restricted Mediterranean diet (erMeDiet) for 16 weeks.', 'armGroupLabels': ['Control group: erMeDiet + placebo capsules', 'Intervention group: erMeDiet + artichoke capsules']}, {'name': 'Placebo capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The control group will consume placebo capsules for 16 weeks.', 'armGroupLabels': ['Control group: erMeDiet + placebo capsules']}, {'name': 'Physical activity', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a recommendation to engage in physical activity (at least 150 minutes/week of moderate physical activity) for 16 weeks.', 'armGroupLabels': ['Control group: erMeDiet + placebo capsules', 'Intervention group: erMeDiet + artichoke capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Idoya Ibero Baraibar', 'role': 'CONTACT', 'email': 'iibero@unav.es', 'phone': '+34948425600'}], 'facility': 'University of Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'centralContacts': [{'name': 'Idoia Ibero, PhD', 'role': 'CONTACT', 'email': 'iibero@unav.es', 'phone': '+34 948 425 744'}], 'overallOfficials': [{'name': 'Sonia García-Calzón, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Navarra'}, {'name': 'Iziar Ludwig, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Navarra'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Navarra', 'class': 'OTHER'}, {'name': 'Hospital of Navarra', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sonia García Calzón', 'investigatorAffiliation': 'Clinica Universidad de Navarra, Universidad de Navarra'}}}}